Home    eJManager.com Add Your Journal   |    Follow on Twitter   |    Subscribe to List

Directory for Medical Articles
 

Open Access

Original Research



Approval of antineoplastic agents in India: comparison with the US and EU regions

Bhaven C. Kataria, Dimple S. Mehta, Sunita B. Chhaiya.

Abstract
Background: The antineoplastic drugs are prescribed for the treatment of cancer, which is an important cause of mortality in India; therefore, a drug lag in the availability of antineoplastic drugs is a direct threat to life. The present study was undertaken to assess the drug lag for new antineoplastic agents in India compared with that in the United States (US) or European Union (EU). Methods: The new antineoplastic agents approved in the United States, European Union and India between 1999 and 2011 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. We assessed absolute and relative drug lag for new antineoplastic agents approved in the three regions. Results: Of the 70 new antineoplastic agents, 64 (91.42%) were approved in the United States, 54 (77.14%) in the European Union and 44 (62.85%) in India. The US was the first to approve 59 (84.28%) out of the 70 new antineoplastic agents, the EU was the first to approve 9 (12.85%) and India was the first to approve 2 (2.85%). The median approval lag for India (26.35 months) was higher as compared to the United States (0 month) and European Union (7.3 months). Conclusions: This study confirms that India's drug lag in the case of new antineoplastic agents is higher as compared to the US and EU. Further detailed analyses are necessary to find the reasons and impacts of drug lag for antineoplastic agents in India.

Key words: Oncology, anticancer drug, marketing approval, drug lag, new drug development


Full text links

Share this Article




ScopeMed Home
Follow ScopeMed on Twitter
Article Tools
Job Opportunities/Service Offers
eJManager OJMS
eJPort Journal Hosting
About ScopeMed
Terms & Conditions
Privacy Policy
Suggest a Journal
Publisher Login
Contact Us

The articles in Scopemed are open access articles licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.
ScopeMed is a Service of eJManager LLC Publishing for Scientific Publications. Copyright © ScopeMedź Information Services.
Scopemed Buttons